The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera

Device Description

The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.

More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).

AI/ML Overview

This document describes the premarket notification 510(k) for the SURGIMESH®XB - Skirted surgical mesh. The provided text outlines the device's characteristics, intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a specific set of acceptance criteria with human readers or standalone algorithm performance.

Here's an analysis of the available information regarding acceptance criteria and supporting studies, formatted as requested, and noting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated but Inferred from Testing Standards)	Reported Device Performance
Biocompatibility	Device must be biocompatible according to ISO 10993-1 standards.	Device demonstrated biocompatibility per ISO 10993-1 standards.
Sterilization Validation	Device must be sterile according to ISO 10993-7, ISO 11137-1, ISO 14937, and USP 28 standards.	Device demonstrated sterility per listed standards.
Product Packaging	Packaging must have appropriate sealing characteristics according to ISO 11607.	Packaging demonstrated appropriate sealing characteristics per ISO 11607.
Device Structure & Material Characterization	Device specifications (mechanical and material characteristics) must be substantially similar to predicate devices based on ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1, and ISO 13938-1 standards.	SURGIMESH®XB - Skirted specifications are substantially similar to identified predicate device specifications.
Functionality/Intended Use	Device must function as intended.	In all instances, the SURGIMESH®XB - Skirted functioned as intended and the results observed were as expected.
Substantial Equivalence	Device must be substantially equivalent to identified predicate devices.	The device was determined to be substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "Preclinical testing was conducted" but does not detail the number of units or samples tested for each criterion.
Data Provenance: The studies were preclinical testing conducted by Aspide Medical. The location of these tests (e.g., country of origin) is not explicitly stated, but Aspide Medical is based in LA TALAUDIERE (FRANCE). The studies are retrospective as they summarize testing that has already been performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The performance data focuses on technical and material characteristics of a surgical mesh, not on expert interpretations of medical images or clinical outcomes that typically require ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The reported tests are objective technical validations against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This document describes a medical device (surgical mesh), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance testing cited are the established international standards (ISO, USP) for biocompatibility, sterility, packaging, and material characterization. The device's performance was compared against these universally recognized technical standards and against the specifications of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a medical device (surgical mesh) testing and substantial equivalence, not the development or training of an AI model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As no AI model or training set is mentioned, there is no ground truth for a training set to be established.

Summary

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PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XB - SKIRTED

510(k) Summary

JUN 2 6 2012

SURGIMESH®XB - Skirted

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

ASPIDE MEDICAL 246 allée Lavoisier 42350 LA TALAUDIERE (FRANCE) Tel: +33 4 77 53 16 59 Fax: +33 4 77 53 01 97

Contact Person; Mr, William Wiecek

Date Prepared: May 4, 2012

Name of Device and Name/Address of Sponsor

SURGIMESH®XB - Skirted

ASPIDE MEDICAL 246 allée Lavoisier 42350 LA TALAUDIERE (FRANCE)

Common or Usual Name

Polymeric Surgical Mesh

Classification Name

Surgical Mesh

Predicate Devices

(1) Apide Medical's SURGIMESH®XB (K072974); (2) Aspide Medical's SURGIMESH®WN (K061445); (3) Gore's DUALMESH (K992189); and (4) Covidien's PARIETEX COMPOSITE OPEN ("PCO") SKIRT Mesh (K110816).

Intended Use / Indications for Use

The SURGIMESH® XB - Skirted mesh is used for the reinforcement of tissues during surgical repair.

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PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XB - SKIRTED

Technological Characteristics

Performance Data

Preclinical testing was conducted. Biocompatibility, product structure, and final product specifications were all tested. In all instances, the SURGIMESH®XB -Skirted functioned as intended and the results observed were as expected. Specifically, the company conducted the following performance testing:

Biocompatibility testing in accordance with ISO 10993-1 standards ● were conducted and results demonstrated that the device is biocompatible per these standards;
Sterilization validation testing in accordance with ISO 10993-7, ISO . 11137-1, ISO 14937, and USP 28 and results demonstrated that the device is sterile per these standards;
Product packaging testing in accordance with ISO 11607 and results . demonstrated that the device packaging has the appropriate sealing characteristics:
The device structure and product characterization testing was . performed in accordance with ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1 and ISO 13938-1 and results demonstrated the SURGIMESH®XB - Skirted specifications are substantially similar to the identified predicate device specifications.

Substantial Equivalence

The SURGIMESH®XB - Skirted is substantially equivalent to: (1) Apide Medical's SURGIMESH®XB (K072974); (2) Aspide Medical's SURGIMESH®WN (K061445); (3) Gore's DUALMESH (K992189); and (4) Covidien's PARIETEX COMPOSITE OPEN ("PCO") SKIRT Mesh (K110816).

The SURGIMESH®XB - Skirted has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the SURGIMESH®XB - Skirted and its

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PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XB - SKIRTED

predicate devices raise no new issues of safety or effectiveness. The SURGIMESH®XB - Skirted mesh's mechanical and material characteristics are substantially equivalent to its predicate devices. Thus, the SURGIMESH®XB -Skirted is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

JUN 2 6 2012

Aspide Medical % Mr. John J. Smith Partner, Hogan Lovells US LLP 555 Thirteenth St, NW Columbia Square Washington, District of Columbia 20004-1109

Re: K120025

Trade/Device Name: SURGIMESH®XB-Skirted mesh Regulation Number: CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: June 19, 2012 Received: June 19, 2012

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. John J. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric L. Keith

£ / Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

120025

510(k) Number (if known):

Device Name: SURGIMESH®XB - Skirted mesh

Indications for Use:

The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krane for UMM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120025

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.